DEVICE: ENDOCAPSULE RECORDER (04953170328244)
Device Identifier (DI) Information
ENDOCAPSULE RECORDER
RE-10
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
RE-10
In Commercial Distribution
OLYMPUS MEDICAL SYSTEMS CORP.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
64666 | Video capsule endoscopy system monitor |
An electrically-powered, portable component of a video capsule endoscopy system designed to be worn by a patient to continuously display and record photographic image data from an ingested video capsule (not included). It typically incorporates a display and controls and may include connection cables. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NEZ | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K183053 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ff32b639-9cd1-4d3d-8194-fde846853efd
April 22, 2024
7
September 21, 2016
April 22, 2024
7
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx